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Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302640
First Posted: March 14, 2006
Last Update Posted: May 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Romark Laboratories L.C.
  Purpose
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

Condition Intervention Phase
Rotavirus Infection Adenoviridae Infection Norovirus Infection Drug: Alinia (nitazoxanide) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Time from first dose to resolution of symptoms. [ Time Frame: P-0.0105 ]
    Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group


Secondary Outcome Measures:
  • Virologic response (negative ELISA) at day 7-10.

Enrollment: 50
Study Start Date: February 2005
Estimated Study Completion Date: September 2005
Arms Assigned Interventions
Active Comparator: Nitazoxanide
7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days
Drug: Alinia (nitazoxanide)
Placebo Comparator: Placebo
7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days
Drug: Alinia (nitazoxanide)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age <12 years.
  • Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
  • Stool positive for adenovirus, norovirus or rotavirus by ELISA.

Exclusion Criteria:

  • Females who are pregnant, suspected of being pregnant or breastfeeding.
  • Other identified causes of diarrhea at screening.
  • Serious systemic disorders incompatible with the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302640


Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Mona Abu-Zekry, MD Cairo University Children's Hospital, Cairo, Egypt
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00302640     History of Changes
Other Study ID Numbers: RM02-3021
First Submitted: March 13, 2006
First Posted: March 14, 2006
Last Update Posted: May 31, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Infection
Communicable Diseases
Diarrhea
Rotavirus Infections
Adenoviridae Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Reoviridae Infections
RNA Virus Infections
Virus Diseases
DNA Virus Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents